| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00223-1 |
| Product Name/Description |
IntelliSpace Portal software version 4.0.2 (Used to remotely access data from networked computers for diagnostic viewing) used with URL PACS integration
ARTG Number: 188684 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
12/03/2013 |
| Responsible Entity |
|
| Reason/Issue |
When loading a study to an analysis application while using URL PACS integration configuration, after another study was opened by a review application, the Analysis monitor is updated with the study of the current patient but the Review monitor continues to display the study from the previous patient. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Philips Healthcare will be installing a software update to address the above identified issue. As a temporary mitigation, the clinicians have been advised that when reviewing two disparate image datasets, not to only be focused on the actual image content but also to be alerted to the patient’s study name and/or ID prior to interpretation. |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |